Title II - RULES OF PROCEDURE FOR THE CONTROL BODIES
CHAPTER IV - Procedures
37. INVESTIGATION PROCEDURE
37.1. Form of Initiation
The procedure will begin with a letter signed by the Director of the Code of Practice Surveillance Unit. This written notice may be submitted in those cases in which the company – having been required in accordance with article 28.4 section (c) – does not provide the Unit with the requested information or documentation, or if said information or documentation is insufficient or incomplete in the judgment of the Unit.
This written notification must be addressed to the representatives designated by the company as legal representatives before Farmaindustria and as Compliance Officer, and must contain at least the following data:
a) Name and address of the company, personal data of the representatives to whom it is directed and date.
b) Explicit request to open the investigation procedure.
c) Brief description of the reasons why the investigation procedure is being initiated. Summary of the presumed activity/practice that is in breach of the terms and provisions of the Code.
Within a period of ten working days from receipt of the request, the company's legal representative before Farmaindustria must report in writing to the Unit regarding their acceptance or rejection of the investigation procedure, including their reasons. Failure to reply within the prescribed period will be understood to be an unjustified rejection of the investigation procedure.
In case of accepting the investigation procedure, the company must also indicate in its document:
a) Its willingness to collaborate in good faith with the activities considered necessary to conduct the investigation procedure.
b) The entity responsible for conducting the investigation, being able to select between:
i) an individual or legal entity that does not have any relationship with the company or any other company in the Group,
ii) an independent auditor that was providing auditing services to the company on the date that the investigation procedure was initiated, or:
iii) the Code of Practice Surveillance Unit.
For cases (i) and (ii), this must be an entity of recognized prestige that is accepted by the Unit. In the Event that an agreement is not reached, the Unit will propose a list of entities from which the company must choose one, within a maximum period of 5 working days from the date of receipt. The costs associated with conducting the investigation procedure by an entity other than the Unit will be assumed, in all cases, by the company.
c) Its submission to the outcome.
Unjustified refusal to submit to the investigation procedure will prompt the Unit to initiate a complaint procedure before the Code of Practice Committee, both to sanction the refusal to collaborate as stipulated in article 21.6 of the Code, as well as the activity that is the object of the investigation.
37.2. Report: Submission, Scope and Content
From the moment of receipt in writing of the acceptance to conduct the investigation procedure, the entity designated to conduct the investigation will have one month to:
i) collect whatever information and documentation can be found in relation to the activity/practice that led to the investigation procedure being initiated, and
ii) provide the Unit (unless this was the entity designated to conduct it) and the company’s legal representative with a written report.
The Unit may agree to extend the time period. Failure to submit the report, or its submission outside of the timeframe – when an entity other than the Unit is responsible for conducting it – will have the effects described in the provisions of section 37.1 concerning the refusal to submit to the investigation procedure.
The report must contain at least the following:
a) A statement of the author of the report as to the veracity of its contents, objectivity in its drafting and the conclusions issued.
b) A detailed description of the investigation work performed, the means employed and the level of collaboration from the company.
c) The company’s internal procedures that would be applicable to an activity/practice such as that which led to the initiation of the investigation procedure. These procedures must include, at least, the areas and persons at the laboratory responsible for supervising its application and compliance, the internal control mechanisms (checklist, sign-off sheets, etc.), the reporting and archiving system, etc.
d) A list of the documentation examined for the purpose of issuing the report, as well as information that, having been requested, was not provided or exhibited by the company. Together with the list, originals or copies of the documents submitted must be provided.
e) Recommendations or proposals for improvement, where applicable.
f) Expressed written authorization to allow the Unit to use the report for any actions it deems appropriate because of their relation to the investigation procedure, including the provisions of section 37.4.
g) The conclusions of the report.
37.3. Collaboration Commitment
The companies subject to the provisions of the Code, as provided in articles 19.1 and 19.3 of the Code, commit to collaborate with the entity in charge of conducting the investigation procedure, providing to this end all information and documentation that said entity requires as useful or necessary for the conduct of its investigative work.
Failure to cooperate with the investigation procedure will have the effects indicated in article 21.6 of the Code and section 37.1 of this article with respect to refusal.
37.4. End of the Procedure
The Unit will have thirty days from receipt of the report or finalization of its drafting, for analysis and review of its contents, holding those meetings it deems appropriate with the persons in charge of the company or with the entity put in charge, where applicable, for drawing up of the report.
Once the deadline has passed, the Unit will have five days to submit a report addressed to the legal representative before Farmaindustria and to the Compliance Officer of the company, indicating:
- The finalization and closure of the investigation procedure.
- The measures to be taken by the Unit in light of the investigation procedure:
(i) closing of the matter, or
(ii) transfer of the recommendations the Unit deems appropriate and closing of the matter, or
(iii) initiation of a complaint procedure before the Code of Practice Committee.